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Seuba, Xavier --- "International harmonization of pharmaceutical standards: trade, ethics and power" [2018] ELECD 1045; in Burci, Gian Luca; Toebes, Brigit (eds), "Research Handbook on Global Health Law" (Edward Elgar Publishing, 2018) 460

Book Title: Research Handbook on Global Health Law

Editor(s): Burci, Gian Luca; Toebes, Brigit

Publisher: Edward Elgar Publishing

ISBN: 9781785366536

Section: Chapter 15

Section Title: International harmonization of pharmaceutical standards: trade, ethics and power

Author(s): Seuba, Xavier

Number of pages: 25

Abstract/Description:

The international harmonization of pharmaceutical standards is promoted both at the normative and institutional level. Guidelines, principles, recommendations and texts of similar legal nature are adopted by technical expert bodies to avoid repetitive tests, reduce risks for human and animal health and cut expenditures for private and public stakeholders. Legitimate reasons, including biological, scientific and climatological factors, may also run against harmonization. There is no international treaty laying down mandatory requirements in this area, but the World Trade Organization Agreement on Technical Barriers to Trade plays a decisive role to determine whether national regulations conform with international standards. From the institutional point of view, international initiatives to ensure medicines’ quality had historically been promoted by World Health Organization expert bodies. However, the International Council for Harmonization may have replaced the World Health Organization. The quality of the standards adopted by this public-private partnership is beyond doubt, but ethics, competition and openness-related concerns have been raised. More broadly, the efficiency and dynamism of the International Council for Harmonization invites to reflect about global health governance adjusted to the twenty-first century challenges and opportunities.